RELI GP822-BRCRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00386120005850), received between Feb 8, 2017 and Feb 8, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 8, 2017Break; Break

  IT WAS REPORTED THAT THE TIP OF THE SUTURE NEEDLE BROKE DURING A TOOTH EXTRACTION PROCEDURE. A PIECE OF THE NEEDLE WAS RECOVERED FROM THE TOOTH SOCKET OF THE PATIENT. UNSURE OF HOW MANY PIECES BROKE OFF FROM THE NEEDLE, AN XRAY WAS USED TO ENSURE THAT THERE WAS NO METAL REMAINING.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6312767 ↗